Hospital patients often undergo treatments of many types using intravenous injections of liquids such as antibiotics, vitamins, drugs, narcotics and many other pharmaceuticals. The injection of the liquid is administered into the veins of the patient. As such, it is important that the intravenous process and equipment remain clean and sterile in order to reduce the possibility of allowing bacteria and other undesirable organisms to enter the body of the patient.
Intravenous solutions may include dextrose solutions, sodium chloride and many other solutions. Such solutions can be injected by intravenous means into a patient, and such solutions can be modified to add other treatment liquids, including those noted above. Intravenous (IV) bags are typically delivered to hospitals or pharmacies with the base solutions of dextrose, sodium chloride, etc. The IV bags are generally delivered within individual protective plastic shipping bags to maintain the IV bags in a sterile condition. The hospital assistant or the pharmacist then removes the IV bags containing the IV solution from the protective plastic cover and discards the latter. In a typical day at many hospitals, clinics and pharmacies, several hundred IV bags may be processed so as to have the proper pharmaceutical solution added to the IV solution, as prescribed by the doctors.
The pharmacist, for example, may have delivered to him/her multiple sheets of adhesive labels from the hospital, where each label is preprinted with information which identifies the patient, the size of the IV bag, the medical solutions to be added, the dosages thereof, and other parameters necessary for the proper administration of IV solutions to the correct patient. The preparation of IV bags for the proper modification of medical solutions is conducted in a clean and sterile environment, usually under a laminar air flow hood. The IV bags are removed from the respective protective coverings in the sterile environment. The pharmacist then identifies the drug to be added to the base IV solution in the bag. The drug is drawn into a syringe, or the like, from a bottle and then added to the IV bag by way of the injection port. The injection port of an IV bag includes a spout or portion extending from the bag, with a self-sealing rubber membrane through which the syringe needle is inserted to inject the drug into the IV bag. When the needle is withdrawn, the rubber membrane reseals to maintain the contents of the IV bag sterile.
Once the base IV solution has been modified in the manner desired, an adhesive seal is applied to the injection port of the IV bag. The adhesive seals are generally of a laminated construction, including a foil and one or more layers of a polypropylene material. The type of seals typically applied to injection ports of IV bags and bottles are disclosed in U.S. Pat. No. 4,266,687 by Cummings; U.S. Pat. No. 4,390,104 by Cummings; U.S. Pat. No. 4,423,819 by Cummings; U.S. Pat. No. 4,514,248 by Cummings; U.S. Pat. No. 4,527,703 by Cummings and U.S. Pat. No. 4,598,834 by Singletary. These seals include a target area surrounded by adhesive. The target area is a non-adhesive spot on the seal that contacts the rubber membrane of the injection port. The surrounding area is adhesive covered for adhering to the surrounding spout portion of the injection port. Importantly, the seal not only maintains the rubber membrane covered and free from bacteria contamination, but the seal includes slits cut therein so that if attempted to be removed, the seal is torn or otherwise destroyed. Accordingly, any tampering of the seal is readily evident. Lastly, the presence of a seal on the injection port of the IV bag is an indication to the pharmacist that the modification of the contents of the IV bag is complete, and no other processing of the IV bag is required. The presence of the seal on the IV container thus prevents the accidental injection therein of an additional medication, or a different medication.
In the manufacture of the IV bag seals noted in the above-identified patents, the target area is free from adhesive in that the adhesive at that spot is covered by a paper dot. The seal also includes a pull tab that has a non-adhesive underside, also covered by paper adhered to the adhesive. Thus, the seal is fabricated by covering the entire underside of the laminated foil/poly strip with an adhesive. Paper is then applied to those areas in which it is desired to be non-adherent. Lastly, a silicone-faced peel strip is attached to the adhesive side of the seal. The peel strip is removed from the seal just prior to use by the pharmacist when applying the seal over the injection port of the IV bag.
While the IV bag seals of the prior art have adequately provided their intended functions, they are not as cost effective as could be. Rather, additional manufacturing steps are required in order to make the laminate structure non-adherent at specified areas. Attempts have been made to make the adhesive areas of the IV bag seals more distinguishable to the pharmacist, as compared to the target area, so that the seal can be easily centered and placed on the spout of the IV bag without allowing adhesive areas of the seal to contact the membrane portion of the spout. To that end, the SecurSeal® tamper evident seal manufactured by Winfield Laboratories of Richardson, Tex., places a color agent in the adhesive to make the adhesive and non-adhesive areas of the seal visually distinguishable to the pharmacist. The colored adhesive is applied to selected surfaces of the seal using screen printing process, where the adhesive is applied through a screen, thereby leaving a pattern of colored adhesive dots. In the areas not to be covered with the adhesive, such as the target area and the pull tab area of the seal, the screen printing process prevents adhesive dots from being applied to such areas.
It can be seen from the foregoing that a need exists for a new seal structure for an IV bag or a bottle, where the seal is economical and thus cost effective, as well as provides an enhanced visual differentiation between the adhesive and non-adhesive areas of the seal. Another need exists for a method of fabricating the seal that does not require substantial modification of conventional screen printing processes to apply the adhesive so that the non-adhesive target area is more easily distinguished from the adhesive areas.